HybridAPC: Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04197180
• Collaborator: Nanfang Hospital of Southern Medical University (Other), Shenzhen Hospital of Southern Medical University (Other), The Fifth Affiliated Hospital of Zunyi Medical College (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 46
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia.

Condition or Disease	Intervention/Treatment	Phase
Gastric Low Grade Intraepithelial Neoplasia	Procedure: Hybrid Argon Plasma Coagulation	N/A

Detailed Description

This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia. Successful ablation is defined as no evidence of local recurrence at 12 months after HybridAPC upon follow up endoscopy. This is defined as absence of LGIN, HGIN and cancer in biopsies obtained at all locations during followup endoscopy.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HybridAPC for the Treatment of Gastric Low Grade Intraepithelial Neoplasia (LGIN): a Prospective, Multi-center Study
• Actual Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hybrid Argon Plasma Coagulation The Hybrid-Argon Plasma Coagulation probe combines waterjet technology with Argon Plasma Coagulation. The probe comprises a central water channel for the submucosa injection function and a peripheral gas channel for the Argon Plasma Coagulation function	Procedure: Hybrid Argon Plasma Coagulation; Argon Plasma Coagulation after water injection for local ablation

Outcome Measures

Primary Outcome Measures

1. Complete ablation of gastric low grade intraepithelial neoplasia [12 months]

   Successful ablation is defined as no evidence of local recurrence at 12 months after HybridAPC upon follow up endoscopy. This is defined as absence of LGIN, HGIN and cancer in biopsies obtained at all locations during followup endoscopy.

Secondary Outcome Measures

1. Operative time [1 day]

   Time to complete the procedure

2. Intraoperative bleeding [1 day]

   Bleeding during the procedure as defined by Grade Definition 0 No bleeding Less bleeding, could be auto-stopped or used by HibridAPC Stop bleeding by using hot forceps Stop bleeding by using clips

3. Pain after procedure [3 days]

   Pain after the procedure as defined by pain score Grade Definition 0 No pain, I Slight pain, II Moderate pain, III Severe pain, IV Extreme pain. V Unbearable pain

4. Development of new neoplasia [12, 24 and 36 months]

   Development of new neoplasia including low grade intraepithelial neoplasia, high grade intraepithelial neoplasia and advanced gastric cancers

5. Progression of Low grade intraepithelial neoplasia [12, 24 and 36 months]

   Progression of the development of low grade intraepithelial neoplasia to high grade intraepithelial neoplasia or advanced gastric cancer

6. Postoperative complications [7 days]

   Development of postoperative complications including bleeding and perforation

7. Number of HybridAPC procedures required for treatment [12 months]

   The number of Hybrid Argon Plasma Coagulation performed for complete ablation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Low grade intraepithelial neoplasia of stomach with size≤20 mm

2. Endoscopic diagnosis suspected gastric LGIN with biopsy confirmed gastric LGIN

3. Endoscopic appearance according to Paris classification of Type 0-IIa, IIb or IIc

4. Patients with informed consent

Exclusion Criteria:

1. Patients who had previous endoscopic treatment (including APC, EMR, ESD) for gastric LGIN, HGIN or gastric carcinoma.

2. Endoscopic evidence of ulcer

3. Biopsy confirmed HGIN

4. Endoscopic diagnosis suspected HGIN while biopsy confirmed LGIN

5. Pregnancy

6. informed consent not available

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Combined Endoscopy Center, Prince of Wales Hospital	Hong Kong		Hong Kong	00000

Sponsors and Collaborators

• Chinese University of Hong Kong
• Nanfang Hospital of Southern Medical University
• Shenzhen Hospital of Southern Medical University
• The Fifth Affiliated Hospital of Zunyi Medical College

Investigators

• Principal Investigator: Philip WY Chiu, MD, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philip Wai Yan CHIU, Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT04197180
• Other Study ID Numbers: CREC 2019.490-T
• First Posted: Dec 12, 2019
• Last Update Posted: May 3, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Philip Wai Yan CHIU, Professor, Chinese University of Hong Kong: Gastric low grade intraepithelial neoplasia; Hybrid APC; Endoscopic Ablation
• Additional relevant MeSH terms: Neoplasms; Carcinoma in Situ

Study Results

No Results Posted as of May 3, 2022